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NY-ESO-1 T Cells in OG Cancer

NCT01795976 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2018-08-07

No results posted yet for this study

Summary

This is a trial of adoptive T cell therapy using the patient's own T cells, genetically engineered to target the tumour associated antigen NY-ESO-1 (New York esophageal squamous cell carcinoma 1). Eligible patients will undergo leukapheresis (a process to remove white blood cells) to retrieve sufficient T cells which will be gene modified and expanded in the laboratory. Patients will undergo preconditioning chemotherapy with cyclophosphamide (60mg/kg) day -7 and day -6, followed by fludarabine (25mg/m2) day -5 to day -1. The NY-ESO-1 gene modified cells will be re-infused on day 0 and the patients will receive up to 14 doses of intravenous Interleukin2 (100000 U/kg) from day 0 to day 4.

The primary objective of response rate according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria will be assessed by CT scans carried out at week 6, week 12 and at 12 weekly intervals thereafter.

Conditions

  • Oesophageal Cancer

Interventions

GENETIC

NY-ESO-1 T cells

DRUG

cyclophosphamide

cyclophosphamide 60mg/kg/day day -7 and day -6

DRUG

Fludarabine

Fludarabine given 25mg/m2 day -5 to day -1

BIOLOGICAL

Interleukin 2

Interleukin 2 (IL2) immunotherapy given day 0 to day 6

Sponsors & Collaborators

  • The Christie NHS Foundation Trust

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Ospedale San Raffaele

    collaborator OTHER

  • University College London Hospitals

    collaborator OTHER

  • Karolinska University Hospital

    collaborator OTHER

  • The Netherlands Cancer Institute

    collaborator OTHER

  • Fiona Thistlethwaite

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01795976 on ClinicalTrials.gov